MAUDE Adverse Event Report: TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE; ANESTHESIA CONDUCTION KIT

Model Number 405671

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that the anesthesia in the tray spn whit25g3.5 l/b-d/e plast drape was ineffective.This was discovered during use.The following information was provided by the initial reporter: material no.405671 batch no.0001300713.It was reported that anesthesia in the tray was ineffective.Over the last few days we had an issue with the bd spinal tray # 405671! our anesthesiologist used couple trays on same patient with no anesthesia at all or just little numbness.It happened today in labor and delivery and also happened in the weekend in the main or with different anesthesiologists.Apparently there is something wrong either manufacturing, storing, or other things, but it is affecting our work flow and patient safety.I am taking those trays out of service.We had an issue before with the tray # 405673, and now we had another issue with 405671.For me it looks like quality and safety issue.We need investigation and information about what bd will do with those complains.We cannot afford having patient incident or safety issue or failed spinal every other day or putting our patient at risk by using unsafe trays.

Manufacturer Narrative

Investigation: one sample was received for evaluation.The vial appears as intended with no obvious defects, the fluid is clear with no sign of contamination, manufacturer¿s coc was provided and accepted as a part of incoming raw material inspection and temperature monitoring data demonstrates the drug was stored under suggested conditions at the mannford facility.All indicators suggest product 405671 lot # 0001300713 contained a drug with acceptable potency.Failure mode could not be confirmed.Over a period of more than 10 years, no test result from samples returned due to ineffective anesthesia has ever failed to meet specifications.The causes of ineffective anesthesia have been well documented in clinical literature for many years.Whereas a strong history of testing has supported that drug potency is not the cause, the actual cause may not always be ascertained.Bd has a long history of test results to support that drug potency issues have not been the cause of ineffective anesthesia events reported to bd through the complaint system.A device history record review of all applicable manufacturing records for lot 0001300713 did not identify any issues that may have contributed to the reported failure mode.Based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.The investigation identified a previous capa (capa 67717) performed by the bd anesthesia quality group that specifically investigated the ¿ineffective anesthesia¿ failure mode.Refer to capa 67717 for additional information regarding the outcome of the investigation.

Event Description

It was reported that the anesthesia in the tray spn whit25g3.5 l/b-d/e plast drape was ineffective.This was discovered during use.The following information was provided by the initial reporter: material no.405671 batch no.0001300713.It was reported that anesthesia in the tray was ineffective.Over the last few days we had an issue with the bd spinal tray # 405671! our anesthesiologist used couple trays on same patient with no anesthesia at all or just little numbness.It happened today in labor and delivery and also happened in the weekend in the main or with different anesthesiologists.Apparently there is something wrong either manufacturing, storing, or other things, but it is affecting our work flow and patient safety.I am taking those trays out of service.We had an issue before with the tray # 405673, and now we had another issue with 405671.For me it looks like quality and safety issue.We need investigation and information about what bd will do with those complains.We cannot afford having patient incident or safety issue or failed spinal every other day or putting our patient at risk by using unsafe trays.

Manufacturer Narrative

H.6.Investigation: one sample was received for evaluation.The vial appears as intended with no obvious defects, the fluid is clear with no sign of contamination, manufacturer¿s coc was provided and accepted as a part of incoming raw material inspection and temperature monitoring data demonstrates the drug was stored under suggested conditions at the mannford facility.All indicators suggest product 405671 lot # 0001300713 contained a drug with acceptable potency.Failure mode could not be confirmed.Over a period of more than 10 years, no test result from samples returned due to ineffective anesthesia has ever failed to meet specifications.The causes of ineffective anesthesia have been well documented in clinical literature for many years.Whereas a strong history of testing has supported that drug potency is not the cause, the actual cause may not always be ascertained.Bd has a long history of test results to support that drug potency issues have not been the cause of ineffective anesthesia events reported to bd through the complaint system.A device history record review of all applicable manufacturing records for lot 0001300713 did not identify any issues that may have contributed to the reported failure mode.H3 other text : see h.10.

Event Description

It was reported that the anesthesia in the tray spn whit25g3.5 l/b-d/e plast drape was ineffective.This was discovered during use.The following information was provided by the initial reporter: material no.405671, batch no.0001300713.It was reported that anesthesia in the tray was ineffective.Over the last few days we had an issue with the bd spinal tray # 405671 our anesthesiologist used couple trays on same patient with no anesthesia at all or just little numbness.It happened today in labor and delivery and also happened in the weekend in the main or with different anesthesiologists.Apparently there is something wrong either manufacturing, storing, or other things, but it is affecting our work flow and patient safety.I am taking those trays out of service.We had an issue before with the tray # 405673, and now we had another issue with 405671.For me it looks like quality and safety issue.We need investigation and information about what bd will do with those complains.We cannot afford having patient incident or safety issue or failed spinal every other day or putting our patient at risk by using unsafe trays.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 8781912
• MDR Text Key: 150848996
• Report Number: 1625685-2019-00069
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: 00382904056711
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: 0001300713
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other